A Phase IIa, Multicenter, Double-Blind, Randomized, Active-Controlled, Parallel-ArmClinical Trial to Study the Efficacy and Safety of MK-0941 Compared to Sulfonylurea inPatients with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on MetforminTherapy - MK-0941 Compared to Glimepiride as Add-on Therapy to Metformi

Conditions: Type 2 diabetes mellitus
MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus

Registration Number: EUCTR2008-005616-40-FI

Lead Sponsor: MSD Finland Oy

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 168

Inclusion Criteria

Patient has type 2 diabetes mellitus (T2DM).
Patient is =18 and =70 years of age on day of signing informed consent.
Patient has a body mass index (BMI) >20 kg/m2 and <43 kg/m2.
Patient is in one of the following categories:
aPatient is currently on single oral AHA and has an A1C =7.5% and =11.0%.
OR
bPatient is on low-dose dual oral AHA combination therapy (i.e., =50% maximum labeled dose of each agent) and has an A1C =7.0% and =10.5%.
Patient is a male, or female unlikely to conceive
Patient has an FPG =140 mg/dL (7.77 mmol/L) and =260 mg/dL (14.43 mmol/L).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis, or patient is assessed by the investigator as possibly having type 1 diabetes confirmed with a C peptide <0.7 ng/mL (0.23 nmol/L).
Patient has a history of severe hypoglycemia defined as two or more episodes during his/her lifetime or one episode within the past year that resulted in hypoglycemic seizures and/or cerebral impairment (e.g., coma, severe confusion, etc.) or patient has had hypoglycemia unawareness (i.e., fingerstick glucose <50 mg/dL [2.8 mmol/L] without symptoms) within the past 3 months.
Patient is on a weight loss program and is not in the maintenance phase, or patient is taking a weight loss medication
Patient has received treatment with an investigational drug within the prior 3 months or is currently participating or planning to participate in another clinical trial during the study or for one month after completing the study.
Patient is on or likely to require treatment with pharmacologic doses of corticosteroids
Patient has undergone a surgical procedure within 30 days prior to signing informed consent or has planned major surgery during the study.
Patient has new or worsening signs or symptoms of coronary heart disease or congestive heart failure within the past 3 months
Patient has poorly controlled hypertension
Patient has a medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C (assessed by medical history), cirrhosis, or symptomatic gallbladder disease.
Patient is HIV positive (as assessed by medical history).
Patient has a clinically important hematological disorder (e.g., aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia).
Patient is currently treated for hyperthyroidism with anti-thyroid medication or radioactive iodine.
Patient has a history of malignancy
Patient is being treated with the following glaucoma medications (or anticipated to be treated with during the study): ecothiophate, pilocarpine, or carbachol.
Patient is allergic to ophthalmologic dilation medications (i.e., cyclophenylate, phenylephrine).
Patient has had, or is anticipated to have, intraocular surgery (incisional surgery) within the past 6 months
Patient has had ocular herpes, uveitis, or iritis within the past 3 months
Patient has a history of intolerance or hypersensitivity to metformin
Patient has a QTc interval >480 ms or has another clinically significant ECG abnormality

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: After 6 weeks of treatment, to assess the effect of the addition of MK 0941 compared with the addition of glimepiride on 24-hour weighted mean glucose (24-hour WMG).;Secondary Objective: Exploratory objectives : <br>(1) After 6 weeks of treatment, to assess the effect of the addition of MK 0941 on 2-hour post-meal glucose (PMG) and fasting plasma glucose (FPG)<br>(2) After 6 weeks of treatment, to assess the rate of hypoglycemia with the addition of MK-0941.<br>(3) After 6 weeks of treatment, to assess the effect of the addition of MK 0941 on body weight.<br>;Primary end point(s): 24-hour weighted mean glucose

Secondary Outcome Measures

Name	Time	Method

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